Soothing Beta Cream for Diaper Rash

ET
MD
Overseen ByMarlene Dytoc, MD/PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to determine whether adding a β-glucan moisturizing cream to routine skin care can enhance skin healing, accelerate visible recovery, reduce discomfort, and improve both patient and clinician experiences. The study will also learn about the safety and tolerability of the β-glucan cream when used along with standard skin care.

The main questions it aims to answer are:

Are there visible changes in the severity of IAD when β-glucan cream is added to standard care, and if so, to what extent does it reduce severity compared with standard care alone?

Does the β-glucan cream help IAD heal faster?

Does the cream reduce symptoms such as pain, itching, tingling, or burning?

What medical problems or side effects, if any, do participants experience while using the β-glucan cream?

Researchers will compare standard care plus β-glucan cream to standard care alone to see if the β-glucan cream provides additional benefit for treating IAD.

Participants will:

Receive either β-glucan cream plus standard care or standard care alone

Have the study cream applied once daily for up to 2 weeks

Have their skin checked weekly by the study team using a standardized assessment tool

Answer questions about symptoms such as pain, itching, tingling, and burning

Allow photographs of the affected skin area to be taken for secure clinical review

Be monitored for any side effects or skin reactions during the study

Who Is on the Research Team?

MD

Marlene Dytoc, MD/PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

Inclusion Criteria

I am an adult with skin irritation from urine or stool leakage.
Expected hospital stay of ≥7 days
Written informed consent obtained directly or via substitute decision-maker

Exclusion Criteria

Pediatric patients
Participants with known hypersensitivities to components of cream (e.g. beta-glucan)
Absence of IAD or incontinence

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either β-glucan cream plus standard care or standard care alone. The cream is applied once daily.

2 weeks
Weekly skin checks by the study team

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of IAD severity and patient-reported outcomes.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Soothing Beta Cream (Dr. Mom)

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Standard care aloneExperimental Treatment1 Intervention
Group II: Adjunctive 0.5% β-glucan cream combined with standard careExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+